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The purpose of this clinical trial is to determine whether laser acupuncture can alleviate dry eye symptoms caused by visual display terminal use and to assess the safety of laser acupuncture. The research questions to be addressed are:
The researchers will compare laser acupuncture and artificial tears with sham laser acupuncture (a procedure using the same device but without activating the laser, so no energy is emitted) to assess whether laser acupuncture and artificial tears can effectively treat dry eye associated with visual display terminal use.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The laser acupuncture and artificial tears therapy |
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| Control Group | Sham Comparator | The sham laser acupuncture and artificial tears therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The laser acupuncture and artificial tears therapy | Device | Laser acupuncture therapy is the application of a Reimers & Janssen LaserPen, with a power of 150mW and a wavelength of 810nm, alternating between Nogier frequencies A and C. The dosage is 2 joules per point, with a therapy duration of 26 seconds per point, targeting bilateral acupuncture points BL2, TE23, ST2, LI4, and ST36. The LaserPen is applied without pressing the laser probe onto the body surface. Artificial tears containing carboxymethylcellulose (CMC) will be used. The frequency of application is four times daily (morning, afternoon, evening, and night), with one drop per eye, administered to both eyes. Artificial tears will be used throughout the study duration (4 weeks). Use of any artificial tears other than CMC will be discontinued for 3 days and resumed on day 4 with CMC. |
| Measure | Description | Time Frame |
|---|---|---|
| The Ocular Surface Disease Index | The Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions designed to assess symptoms of dry eye, visual function, and environmental factors that may trigger dry eye. | Before therapy, week 2, week 4 |
| The Tear Break-up Time | Tear Break-Up Time (TBUT) is an examination used to assess how long the tear film remains on the ocular surface after blinking, as a measure for diagnosing dry eye. This test is conducted by an ophthalmologist. | Before therapy, week 2, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The Ocular Surface Staining Score | Ocular Surface Staining (OSS) score is a scoring of examination in which dye is applied to the ocular surface to detect abnormalities on the eye's surface. | Before therapy, week 2, week 4 |
| The Schirmer Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KPEK FKUI-RSCM | The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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This study will compare the combination of laser acupuncture therapy and artificial tears with the combination of sham laser acupuncture therapy and artificial tears.
The laser acupuncture and artificial tears therapy will be designated as the intervention group, while the sham laser acupuncture and artificial tears therapy will be designated as the control group.
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The participants, the ophthalmologist conducting the eye examinations, and the outcome assessors will be blinded to group allocation.
|
| The sham laser acupuncture and artificial tears therapy | Device | Laser acupuncture therapy is a procedure using the same device but without activating the laser, so no energy is emitted. Performed at the same points as laser acupuncture therapy. Artificial tears containing carboxymethylcellulose (CMC) will be used. The frequency of application is four times daily (morning, afternoon, evening, and night), with one drop per eye, administered to both eyes. Artificial tears will be used throughout the study duration (4 weeks). Use of any artificial tears other than CMC will be discontinued for 3 days and resumed on day 4 with CMC. |
|
The Schirmer score is an accumulation of tear volume over a period of 5 minutes.
| Before therapy, week 2, week 4 |
| The Visual Analog Scale | The Visual Analog Scale (VAS) is a scoring tool to measure the intensity of discomfort associated with dry eye, using a scale from 0 to 100, where 0 indicates "no pain/discomfort" and 100 indicates "the most severe pain/discomfort." | Before therapy, week 2, week 4 |
| Adverse Event | Symptoms reported by patients after receiving laser acupuncture therapy. | Up to week 4 |